Sterile & Non-Sterile Preparations Flashcards

Which ISO cleanroom classification is required for the preparation of sterile injectable medications?

Answer: ISO 5 (Class 100) for the critical zone within a laminar airflow workbench

Sterile product compounding requires the critical working zone to be ISO 5 (Class 100), ensuring ≤100 particles ≥0.5 µm per cubic foot to prevent microbial and particulate contamination.

What is the purpose of a biological safety cabinet (BSC) Class II in pharmacy aseptic compounding?

Answer: To protect both the operator and the product from hazardous drug contamination using vertical unidirectional airflow

A Class II BSC uses vertical laminar airflow and HEPA filtration to simultaneously protect the pharmacist from exposure to cytotoxic/hazardous drugs and maintain product sterility.

Which sterilisation method is preferred for heat-stable aqueous injectable preparations?

Answer: Moist heat sterilisation (autoclaving at 121°C, 15 psi, 15–20 minutes)

Autoclaving uses saturated steam under pressure (121°C, 15 psi) to achieve the most reliable and validated sterilisation for heat-stable aqueous pharmaceutical preparations.

What does the endotoxin (pyrogen) test in sterile preparation quality control detect?

Answer: Bacterial endotoxins (lipopolysaccharides from Gram-negative bacteria) that can cause fever and septic reactions

Endotoxin (pyrogen) testing using the Limulus Amebocyte Lysate (LAL) assay detects Gram-negative bacterial endotoxins that survive sterilisation and can cause severe febrile reactions when injected.

Why must cytotoxic drug preparation be performed in a negative pressure environment?

Answer: To prevent hazardous drug aerosols from escaping the preparation area and exposing pharmacy staff

Negative pressure environments prevent hazardous aerosolised cytotoxic drug particles from being pushed out into the pharmacy, protecting staff from carcinogenic and mutagenic exposure.

What is an 'expiry date' versus a 'beyond-use date' (BUD) in pharmacy compounding?

Answer: Expiry date is assigned by the manufacturer; BUD is the date after which a compounded or opened preparation must not be used

Manufacturer-assigned expiry dates apply to commercially produced products; a beyond-use date is assigned by the pharmacist to compounded preparations or opened products based on stability data and storage conditions.